Interleukin-2 in Treating Patients With Metastatic Melanoma
Launched by BLUMENTHAL CANCER CENTER AT CAROLINAS MEDICAL CENTER · Aug 23, 2004
Trial Information
Current as of June 22, 2025
Unknown status
Keywords
ClinConnect Summary
OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess the toxicity of this regimen.
OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; t...
Gender
ALL
Eligibility criteria
- • DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major nerve Measurable disease required
- • PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than 80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women
- • PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma
About Blumenthal Cancer Center At Carolinas Medical Center
The Blumenthal Cancer Center at Carolinas Medical Center is a leading institution dedicated to advancing cancer research and treatment through innovative clinical trials. As part of the Atrium Health network, the center integrates cutting-edge technology with a patient-centered approach, offering comprehensive care that includes personalized treatment plans and access to the latest therapeutic options. With a multidisciplinary team of experts, the Blumenthal Cancer Center focuses on improving patient outcomes and enhancing the understanding of cancer biology, making significant contributions to the field of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlotte, North Carolina, United States
Patients applied
Trial Officials
Richard L. White, MD
Study Chair
Blumenthal Cancer Center at Carolinas Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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